Skip to content

Ceiba Tele ICU Sağlik Hi̇zmetleri̇ Ve Ti̇caret A.Ş.

by Ceiba Tele ICU Sağlik Hi̇z.ve Ti̇c.a.ş 4 variants

Ref ECLN-1002

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number86826012229YAZI01H3 Basic UDI-DI 08682601222917UDI-DIDate8 Mar 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
EConnect Medikal Cihaz Hastane Enformasyon Sistem Yazılımı
Model / Reference
ECLN-1002
Primary DI / UDI-DI
08682601222917
Basic UDI-DI
86826012229YAZI01H3
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class I
Special Device Type
Software
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000019342

Other devices from Ceiba Tele ICU Sağlik Hi̇z.ve Ti̇c.a.ş

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No